Increasing the Oral Bioavailability of 6-prenylnaringenin by Micellar Solubilization

NCT ID: NCT03286777

Last Updated: 2018-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-22

Study Completion Date

2018-07-01

Brief Summary

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Micellar encapsulation will be tested to increase the oral bioavailability in humans of 6-prenylnaringenin (6-PN) from hops (Humulus lupulus). The study follows a single dose (250 mg 6-PN), placebo controlled, randomized, double-blind, three armed crossover study design with ≥2-week washout periods. Plasma, urine and PBMC samples will be collected at intervals up to 24 h after intake of the native compound, the micellar formulation or placebo. The safety, pharmacokinetics and impact of oral prenylflavonoids on PBMC survival will be investigated.

Detailed Description

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Conditions

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Safety of Native vs. Micellar 6-PN After Oral Intake Pharmacokinetics of Native vs. Micellar 6-PN After Oral Intake PBMC Activity After Native vs. Micellar 6-PN Oral Intake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Mannitol and silicon dioxide

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Mannitol and silicon dioxide capsules

Native 6-prenylnaringenin

250 mg native 6-PN plus mannitol and silicon dioxide

Group Type EXPERIMENTAL

Native 6-prenylnaringenin

Intervention Type DIETARY_SUPPLEMENT

250 mg native 6-PN plus mannitol and silicon dioxide capsules

Micellar 6-prenylnaringenin

250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant

Group Type EXPERIMENTAL

Micellar 6-prenylnaringenin

Intervention Type DIETARY_SUPPLEMENT

250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant capsules

Interventions

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Placebo

Mannitol and silicon dioxide capsules

Intervention Type DIETARY_SUPPLEMENT

Native 6-prenylnaringenin

250 mg native 6-PN plus mannitol and silicon dioxide capsules

Intervention Type DIETARY_SUPPLEMENT

Micellar 6-prenylnaringenin

250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant capsules

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers with blood chemistry values within normal ranges
* Age: 18-45 years
* BMI: 19-25 kg/m2

Exclusion Criteria

* Pregnancy or lactation
* Alcohol and/or drug abuse
* Use of dietary supplements or any medications, except contraceptives
* Any known malignant, metabolic and endocrine diseases
* Previous cardiac infarction
* Dementia
* Participation in a clinical trial within the past 6 weeks prior to recruitment
* Physical activity of more than 5 h/wk
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universität Tübingen

OTHER

Sponsor Role collaborator

University of Hohenheim

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Frank, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Hohenheim

Sascha Venturelli, Dr. med. Dr. rer. nat.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Eberhard Karls University Tuebingen, Germany

Christian Busch, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Eberhard Karls University Tuebingen, Germany

Locations

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University of Hohenheim

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Eberhard Karls University Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Related Links

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http://www.nutrition-research.de/

Website of the research group

Other Identifiers

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HS-PF2-2017

Identifier Type: -

Identifier Source: org_study_id

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